HbA1c Estimation Research Articles

The Research on Factors Influencing Diabetes

Diabetes is a serious disease for people, causing massive damage to body. However, people learn a little about the diabetes, showing that it is very important to analyze the relationships between diabetes and several factors. We incorporate multiple factors such as age and gender into a unified framework to jointly test the impact of multiple factors on the dependent variable. Whether a person owning the diabetes is been seen as the result. This paper established logistic regression model and using a comprehensive dataset sourced from Kaggle containing these factors to estimate paraments and using F1-score and Receiver Operating Characteristic (ROC) curve to evaluate the whole model. The results show that the estimation of parameter HbA1c is 2.53, playing the most important role in the diabetes. Blood glucose, Age, and BMI account, either. Apart from that, it could be learned from the Stand Error (SE) and P-value about the accuracy. The characters of F1-score and ROC curve show that this model performs exceptionally well in identifying diabetes cases. A conclusion could be drawn that a person could try to exercise or improve diet to release the symptom of diabetes.

Clinical Risk Assessment and Comparison of Bias between Laboratory Methods for Estimation of HbA1c for Glycated Hemoglobin in Hyperglycemic Patients.

Hemoglobin A1c (HbA1c), also known as glycated hemoglobin, is a blood test used to evaluate and track a patient's blood sugar levels over the previous 2-3 months. We have compared the analytical performance of the D10 hemoglobin (HPLC) testing system to that of the immunoturbidimetric technique, which is a light-scattering immunoassay. To assess the clinical risk assessment between two methods (Compare the two Immunoturbidometric methods (AU680) vs. HPLC method (D10)) in hyperglycemic patients and assess the acceptability of the respective methods in the Clinical biochemistry laboratory. The charge of the globins in Hb was used as the basis for the HPLC method used to measure HbA1c. HPLC detects and quantifies even the tiniest Hb fractions and the full spectrum of Hb variants. HbA1c was measured using the immunoturbidimetric (AU 680 Beckmann coulter analyzer) and high-performance liquid chromatography (HPLC) techniques. Experiments also made use of immunoturbidimetric techniques (using an AU 680 Beckmann coulter analyzer equipment). There is no statistically significant difference in HbA1c readings between male and female patients, as measured by either the Immunoturbidimetric or HPLC techniques. The immunoturbidimetric and high-performance liquid chromatography techniques for estimating HbA1c yielded identical results. From the results of this study, we may deduce that both techniques are valid for estimating HbA1c. As a result, it may be suggested that both approaches can be used to estimate HbA1c in diabetic individuals.

Assessment of glycemic control and correlation of HbA1c level with lipid profile and duration of diabetes in type 2 diabetes mellitus patients

Background & Objectives: The prevalence of Type 2 diabetes mellitus, or Type 2 DM, is rising globally. A periodic estimation of HbA1c has been recommended to track the state of glycemic control of Type 2 DM patients, in order to control the diabetes associated disorders. The main consequence and cause of death in Type 2 diabetes has been identified as cardiovascular disease (CVD).Optimization of glycemic status along with decreasing CVD risk factors are critical to preventing morbidity and mortality in patients with Type 2 DM. Since there is a lack of data on these CVD risk factors, in Madhesh Province, Nepal, we aimed to evaluate the glycemic status, estimate the lipid profile, and ascertain their correlation, including duration of Type 2 DM among patients in tertiary care hospitals in Madhesh Province, Nepal. Materials and Methods: The tertiary care hospital based cross-sectional study was conducted on 139 Type 2 DM patients, in Madhesh Province, Nepal. In order to gather information of the participants, a systematic questionnaire was introduced. A physical and clinical examination was performed, and an appropriate volume of blood was drawn with prior written consent. The lipid profile parameters, HbA1C, Fasting and post prandial serum glucose were estimated. Results: In 84 (60.3%) and 106 (76.3%) cases, there was an increased fasting and postprandial blood sugar. The mean±SD HbA1c level was 8.40±0.8%. More than half (52.5%) of the patients had poor glycemic control, while 22.3% had inadequate glycemic control, in reference to HbA1c >8% and 7 to 8%, respectively. A substantial increased level of LDL-C, triglycerides and total cholesterol was observed in 122 patients and 85.6% had reduced HDL-C. A significant strong positive association was found between HbA1c level and total cholesterol and triglycerides, in contrast, no discernible association with duration of disease observed. Conclusion: Glycemic control was inadequate. Triglycerides and total cholesterol were significantly positively correlated with HbA1c, but not with HDL-C, LDL-C, or the course of diabetes.

Design and Validation of a Monte Carlo Method for the Implementation of Noninvasive Wearable Devices for HbA1c Estimation Considering the Skin Effect.

To diagnose diabetes early or to maintain stable blood glucose levels in diabetics, blood glucose levels should be frequently checked. However, the only way to check blood glucose levels regularly is to use invasive methods, such as pricking the fingertip or using a minimally invasive patch. These invasive methods pose several problems, including being painful and potentially causing secondary infections. This study focuses on noninvasively measuring glycated hemoglobin (HbA1c) using PPG signals. In particular, the study relates to a method and a hardware design technology for removing noise that may be present in a PPG signal due to skin contact with a noninvasive HbA1c measurement device. The proposed HbA1c measurement device consists of the first sensor (PPG sensor) module including an optical barrier and the second sensor (cylindrical sensor) module for removing the skin effect. We have developed a Monte Carlo method to implement accurate, noninvasive HbA1c measurement by considering different skin properties among different subjects. Implementing this model in wearable devices will allow end users to not only monitor their glycated hemoglobin levels but also control diabetes with higher accuracy without needing any blood samples. This will be a groundbreaking advancement in modern wearable medical devices.

Diabetes Self-Efficacy on Glycemic Control and Well-Being of Patients With Type 2 Diabetes Mellitus: An Analytical Cross-Sectional Study.

Diabetes mellitus is a major, chronic, and progressive lifestyle disease. It adversely affects patients' quality of life, effectiveness, and well-being. Self-care practices are universally recognized as imperative to keep the illness under control and prevent complications. Self-efficacy is one of the factors involved in the successful self-care of diabetic patients. The primary objective of the study was to estimate the proportion of diabetes self-efficacy and to assess the correlation ofdiabetes self-efficacy with glycemic control, and the well-being of patients with type 2 diabetes mellitus (T2DM). The secondary objective was to assess the factors associated with diabetes self-efficacy. An analytical cross-sectional study was conducted among T2DM patients attending the non-communicable disease clinic in the outreach centers of Government Medical College, Thiruvananthapuram, Kerala, India. Four hundred patients with T2DM were included in the study.Diabetes self-efficacy was assessed by the Stanford Diabetes Self-Efficacy Scaleand the WHO-5 index scale was used to assess wellbeing. Glycemic control was determinedby HbA1C estimation, with ≤7% as good control. Among 400 patients with T2DM, 51.25 % (95% CI: 46.2-56.2) had high diabetes self-efficacy. A significantly negative correlation was found between HbA1C and self-efficacy (r =- 0.208, p = 0.01), and a positive correlation was shown between well-being and self-efficacy (r = 0.418, p = 0.01). Logistic regression analysis found that factors associated with diabetes self-efficacy were upper socioeconomic status (OR = 8.53, 95% CI: 3.06-13.82), family support (OR = 1.97, 95% CI: 1.10-3.54), participation in diabetes education classes (OR = 1.95, 95% CI: 1.10-3.54), diet compliance (OR = 4.74, 95% CI: 2.80-8.01), glycemic control (OR = 1.69, 95% CI: 1.01-2.84), and overall wellbeing (OR = 6.7, 95% CI: 3.84-11.64). The proportion of high diabetes self-efficacy was 51.25% (95% CI: 46.2-56.2). The factors associated with diabetes self-efficacy were family support, participation in diabetes education classes, high socioeconomic status, absence of complications, good glycemic control, and well-being. The study findings depicted that high self-efficacy was significantly correlated with good glycemic control and well-being of patients with T2DM.

The Association of High and Low Glycation With Incident Diabetic Retinopathy in Adults With Type 1 Diabetes.

We investigated the risk of incident diabetic retinopathy (DR) among high glycator compared to low glycator patients based on the hemoglobin glycation index (HGI). Visit-to-visit variations in HGI also were assessed. Glycated hemoglobin (HbA1c) and continuous glucose monitoring data were collected up to 7 years prior to the date of eye examination defining incident DR or no retinopathy (control). Hemoglobin glycation index was calculated as difference in measured HbA1c and an estimated A1c from sensor glucose (eA1c) to define high (HbA1c - eA1c >0%) or low (HbA1c - eA1c <0%) glycator. Stable glycators were defined as ≥75% of visits with same HGI category. Logistic regression was used to assess the association between glycation category and incident DR. Of 119 adults with type 1 diabetes (T1D), 49 (41%) were stable low glycator (HbA1c - eA1c <0%), 36 (30%) were stable high glycator (HbA1c - eA1c >0%), and 34 (29%) were unstable glycator. Using alternate criteria to define high vs low glycator (consistent difference in HbA1c - eA1c of > 0.4% or <0.4%, respectively), 53% of the adults were characterized as unstable glycator. Compared to low glycators, high glycators did not have a significantly higher risk for incident DR over time when adjusted for age, T1D duration and continuous glucose monitoring (CGM) sensor type (odds ratio [OR] = 1.31, 95% confidence interval [CI] = 0.48-3.62, P = .15). The risk of diabetic retinopathy was not found to differ significantly comparing high glycators to low glycators in adults with T1D. Moreover, HbA1c - eA1c relationship was not stable in nearly 30% to 50% adults with T1D, suggesting that discordance in HbA1c and eA1c are mostly related either HbA1c measurements or estimation of A1c from sensor glucose rather than physiological reasons.

Comparison of Glycated Hemoglobin (HbA1c) Values Estimated by High-Performance Liquid Chromatography and Spectrophotometry: A Pilot Study.

Background Invasive blood sample collection followed by high-performance liquid chromatography (HPLC) based analysis is the gold standard for estimating glycated hemoglobin level or HbA1c currently. Spectrophotometry could be an alternative that holds the potential to be translated into a portable, non-invasive device for glycated hemoglobin level estimation. This study compares HbA1c values obtained from HPLC and spectrophotometry. Methods Venous blood samples were collected from both diabetic and non-diabetic participants in a cross-sectional study. The samples were subjected to both HPLC and spectrophotometry-based estimation of HbA1c%. The results obtained were compared, and the relationship between the two estimations were assessed. Results About 15 diabetic and non-diabetic individuals participated in the study and 28 samples were included in the final analysis. The Pearson's correlation coefficient was 0.65 (95% CI, 0.37-0.82), indicating that there was a strong positive association. This was further supported by the findings from linear regression analysis with a p-value of <0.001. Conclusions The positive correlation between the HPLC and spectrophotometric values supports the hypothesis that spectrophotometry could be an alternative to conventional HPLC for the measurement of HbA1c. This needs to be further validated through larger, well-powered studies.

Comparison of HbA1c Estimation by Enzymatic and HPLC Methods

Comparison of HbA1c Estimation by Enzymatic and HPLC Methods

Estimation of HbA1c for DMT2 risk prediction on the Mexican population based in Artificial Neural Networks

In this paper, the main objective is to estimate the percentage of glycosylated hemoglobin through an easily accessible computational platform to estimate the risk of generating type 2 diabetes mellitus in the Mexican population. The estimation of the computational tool is developed through an artificial neural network model, which was trained and validated according to a population sample of 1120 Mexican people between 18 and 59 years old. The model inputs were gender, age, body mass index, waist circumference, weekly food consumption, family history, and whether the person suffers from any chronic degenerative disease other than T2DM. We used the percentage of glycosylated hemoglobin as output, estimated according to a dynamic glucose model. The estimation results present a coefficient of determination of 99 %, demonstrating an acceptable performance of the neural network model. The developed platform is an aid tool for health personnel, which seeks to generate a first approximation to the glycemic status of those communities with a high marginalization index for generating disease prevention strategies.

Evaluation of neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) as inflammatory markers in patients with type 2 diabetes mellitus

Diabetes Mellitus (DM), chronic metabolic disease and its complications are diabetic nephropathy, retinopathy, and neuropathy. Systemic inflammation play a significant role and could lead to insulin resistance. This study aimed to investigate NLR and PLR in T2DM patients in comparison with healthy controls. This prospective study, conducted in SRVS Government Medical College, Shivpuri, Madhya Pradesh, India. In this study, a total of 220 subjects were involved, among them 110 were T2DM patients were cases and 110 healthy subjects were controls. Demographic details, physical and clinical examination were done for all the study subjects. Under aseptic conditions, five ml of fasting venous blood sample was collected and aliquoted into plain (3ml) and EDTA (2 ml) tubes and allowed to clot and centrifuged at 3000 rpm for 10 minutes. The obtained serum sample was used for the estimation of fasting and post-prandial glucose, renal profile, lipid profile using commercially available autoanalyzer kits. Whole blood sample was used for the Complete Blood Count (CBC) in EDTA vials. Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte (PLR) were calculated. Whole blood sample was used for the estimation of HbA1c and BMI was calculated.The variables were represented in Mean±SD. Categorical variables were represented in percentage. Spearman’s correlation was applied. The p value &amp;#60;0.05 considered as significant.In the current study, mean age 60.2±4.2 yrs, BMI 27.1±2.4 (kg/m), Systolic blood pressure 132.1±12.3 mmHg, Diastolic blood pressure 90.2±10.5 mmHg, fasting blood sugar (FBS) 169.7±19.3 mg/dl, Post-Prandial blood sugar 238.1±39.5 mg/dl, HbA1c 7.9±0.8 %, Serum Urea 36.1±7.1 mg/dl, Creatinine 1.0±0.3 mg/dl, UA 6.5±2.3 mg/dl, Serum Total Cholesterol 241.1±30.5 mg/dl, Serum Triglycerides 170.0±16.2 mg/dl, Serum low density lipoprotein cholesterol (LDLC) 176.4±35.2 mg/dl, Serum very low density lipoprotein cholesterol (VLDL) 34.1±3.2 mg/dl, Lymphocytes 17.2±4.1 %, NLR 6.7±2.3 and PLR 19.1±6.9 were significantly increased in Type 2 Diabetes Mellitus (T2DM) cases whereas high low density lipoprotein cholesterol (HDLC) 30.7±3.9 mg/dl was significantly decreased in T2DM cases.The present study results may conclude that increased NLR and PLR may be used as a markers for inflammation in T2DM. These may serve as an alternative to the other costly inflammatory markers.

Estimation of HbA1c after weight loss using a beta-regression for an economic evaluation of a behavioural weight management programme from the GLoW trial: a methodological study

BackgroundIn economic evaluations, average intervention effects are usually applied to a population. However, this fails to reflect the change in the distribution of HbA1c due to heterogeneous responses to weight loss. We aimed to investigate whether allowing heterogeneous treatment effects using a beta regression better represented the distribution of HbA1c after a weight-loss intervention, and how this affected cost effectiveness. MethodsThe Glucose Lowering through Weight Management (GLoW) trial evaluated the effectiveness of a diabetes education and weight-loss intervention against a standard diabetes education programme. Adults diagnosed with type 2 diabetes within 3 years were recruited from Clinical Commissioning Groups across 159 sites in England from July 20, 2018, to July 22, 2018. Ethics approval (18/ES/0048) and participant informed consent were obtained. Considering the between-treatment-arm difference in HbA1c after 12 months, we compared a mean-effect estimated from a mixed-effects regression to a heterogeneous effect estimated from a beta regression performed on 12-month HbA1c conditional on baseline HbA1c, gender, diabetes duration and intervention group. We used the School of Public Health Research (SPHR) Diabetes Treatment model to apply these treatment effects and evaluate the lifetime NHS costs and quality-adjusted life-years (QALYs), discounted at 3·5%. The microsimulation model estimated diabetes-related health outcomes using the UK Prospective Diabetes Study Outcomes Model 2 risk equations and risk factor trajectory equations, alongside estimating diabetes remission, osteoarthritis, and cancer. We calculated the incremental net benefit (INB) of the intervention using a £20 000 per QALY valuation, by deterministic analysis. The GLoW trial is registered with the ISRCTN Registry, ISRCTN18399564. FindingsThe trial recruited 577 participants (mean age 60 years; 278 [53%] female, 247 [47%] male; 474 [91%] white ethnic background). Applying heterogeneous HbA1c changes better reproduced the skewness in post-intervention HbA1c than applying a mean-effect (Kolmogorov-Smirnov test p=0·02 compared with p=0·0000007). The beta-regression method suggested the intervention was more cost-effective, estimating an INB of £736 per person, compared with £584 when applying the mean-effect. InterpretationAlternative regression specification methods should be considered when evaluating the cost-effectiveness of interventions if the key intervention outcomes are not normally distributed. However, this alternative method requires further investigation to conclude its appropriateness in evaluating cost-effectiveness in different contexts. FundingNational Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (Reference Number RP-PG0216-20010).

Evaluation of Reduced Glutathione Plasma Level in Type 2 Diabetic Patients with Fatty Liver

Abstract Type 2 diabetes (T2DM) and its complications represent a main worldwide public health challenge, with high-rate morbidity and mortality. Non-alcoholic fatty liver disease (NAFLD) has a great focus worldwide, as it is expected to affect 75% of patients with type2 diabetes mellitus. In this study, we aimed to assess reduced glutathione plasma level then evaluate its correlation with fasting blood glucose levels, HBA1c and lipid profile in type 2 diabetic patients with fatty liver. This study included 40 participants divided into 20 type2 diabetics with fatty liver group and 20 healthy control group. Estimation of fasting blood glucose levels, HBA1c, lipid profile and liver function enzymes were done. reduced glutathione plasma levels were measured by ELISA. The results revealed that plasm levels of reduced glutathione were lower in type 2 diabetics with fatty liver compared to control subjects (P &amp;lt; 0.01). These low plasma GSH levels in diabetics was negatively correlated with FBG and HBA1C% (r= −0.641, −.0547 respectively; P &amp;lt; 0.01) indicating that chronic hyperglycemia and its resulted oxidative stress have negative impact on GSH concentrations in the body. This low GSH levels in type 2 diabetics with fatty liver can be an important prognostic factor as, GSH reduction causing increase of oxidative stress and may worsen the liver status that may progress to NASH.

Estimated glucose disposal rate (eGDR) in rural Bangladeshi population and its correlation with cardiometabolic risks

Background and objectives: For decades type 2 diabetes mellitus (T2DM) and insulin resistance (IR) are increasingly gaining importance as an underlying mechanism for increased risk of cardiovascular diseases (CVD). IR is related to various cardiometabolic adverse effects. Hyperinsulinemic-euglycemic clamp technique, the gold standard method for measuring IR, is an invasive and complex procedure. Estimation of glucose disposal rate (eGDR) is an easy alternative tool for measuring IR. There is no known study on eGDR level in Bangladeshi native population. Therefore, this study was undertaken to determine the eGDR values in a healthy working rural Bangladeshi population. Materials and methods: Six villages were selected purposively as the study sites. All healthy working people aged ≥20 years in selected rural community were considered eligible. Those who consented to participate in the study were enrolled. Investigations included a) interviewing for social and clinical history, b) anthropometry and measurement of blood pressure and d) estimation of HbA1c and biochemical indices. The eGDR (mg/kg/min) was calculated using formula: eGDR = 21.158 − (0.09 * WC) − (3.407 * HT) − (0.551 * HbA1c); where WC = waist circumference in cm, HT = hypertension (yes = 1/no = 0), and HbA1c = HbA1c (%). Results: A total of 93 (m/w = 29/64) participants were enrolled in the study. The prevalence rates of hypertension, diabetes and metabolic syndrome (MSyn) were 34%, 31.1% and 16.1%, respectively. The mean eGDR value was 9.9 (±0.149; 95% CI: 9.62–10.2) mg/kg/min. Most of the values of biophysical characteristics were normal. The comparison between participants with and without MSyn showed that the former had significantly lower eGDR (9.05±1.24 vs.10.10±1.37, p&lt;0.01). Inverse correlations of eGDR with the obesity, glycemia and lipidemia (weight, waist, FBG, T-chol, and TG) were significant. Declining eGDR were significant with rising WHR, WHtR, TG/HDLR and T-chol/HDLR (for all, p&lt;0.05). Conclusions: The study revealed the level of eGDR in a healthy working people of a rural community of Bangladesh. Moreover, eGDR was found to decrease significantly with the increasing cardiometabolic risks. The study revealed a higher prevalence of hypertension, diabetes and metabolic syndrome in apparently healthy working people highlighting susceptibility of Bangladeshi natives to non-communicable diseases. IMC J Med Sci. 2023; 17(2):005. DOI: https://doi.org/10.55010/imcjms.17.015 *Correspondence: M Abu Sayeed, Department of Community Medicine, Ibrahim Medical College, 1/A, Ibrahim Sarani, Segunbagicha, Dhaka 1000, Bangladesh. Email: sayeed1950@gmail.com

Noninvasive In Vivo Estimation of HbA1c Based on the Beer–Lambert Model from Photoplethysmogram Using Only Two Wavelengths

Glycated hemoglobin (HbA1c) is the most important factor in diabetes control. Since HbA1c reflects the average blood glucose level over the preceding three months, it is unaffected by a patient’s activity level or diet before a test. Noninvasive HbA1c measurement reduces both the pain and complications associated with fingertip piercing to collect blood. Photoplethysmography is helpful for measuring HbA1c without blood samples. Herein, only two wavelengths (615 and 525 nm) were used to estimate HbA1c noninvasively, where two different ratio calibrations were applied and their performances were compared to a work that used three wavelengths. For the fingertip type, the Pearson’s r values for HbA1c estimates were 0.896 and 0.905, considering the ratio calibrations for the blood vessel and whole finger models, respectively. Using another value (HbA1c) calibration in addition to the ratio calibrations, we could improve this performance such that the Pearson’s r values of the HbA1c levels were 0.929 and 0.930 for the blood vessel and whole finger models, respectively. In a previous study, using three wavelengths, the Pearson’s r values were 0.916 and 0.959 for the blood vessel and whole finger models, respectively. Here, the RCF of the SpO2 estimation was 0.986 when the SpO2 ratio calibration was applied, while in a previous study, the RCF values of the SpO2 estimation were 0.983 and 0.986 for the blood vessel and whole finger models, respectively. Thus, we have shown that HbA1c estimation using only two wavelengths has a comparable performance to previous studies.

Study of the Effect of Smoking on Glycemic Status: A Clinical Study on Indian Sub-population

Smoking has been known to be a major risk factor for diabetes in several clinical studies. The present study aimed to investigate the effect of smoking cessation on glycemic status during diabetic treatment regimes. The study was carried out on 200 patients with type 2 diabetes mellitus and 30 healthy controls. Fasting blood sugar, HbA1C estimation and lipid profiling were examined. A significant (p &lt; 0.001) difference between 1st day and after 6 months of HbA1C value was observed in smoking cessation individuals. This study indicated the effect of short term cessation of smoking in diabetics also increase BMI and disturbs glycemic control. Tight glycemic control is recommended so that long term effects of smoking can be prevented.

Non-Invasive In Vivo Estimation of HbA1c Using Monte Carlo Photon Propagation Simulation: Application of Tissue-Segmented 3D MRI Stacks of the Fingertip and Wrist for Wearable Systems

The early diagnosis of diabetes mellitus in normal people or maintaining stable blood sugar concentrations in diabetic patients requires frequent monitoring of the blood sugar levels. However, regular monitoring of the sugar levels is problematic owing to the pain and inconvenience associated with pricking the fingertip or using minimally invasive patches. In this study, we devise a noninvasive method to estimate the percentage of the in vivo glycated hemoglobin (HbA1c) values from Monte Carlo photon propagation simulations, based on models of the wrist using 3D magnetic resonance (MR) image data. The MR image slices are first segmented for several different tissue types, and the proposed Monte Carlo photon propagation system with complex composite tissue support is then used to derive several models for the fingertip and wrist sections with different wavelengths of light sources and photodetector arrangements. The Pearson r values for the estimated percent HbA1c values are 0.94 and 0.96 for the fingertip transmission- and reflection-type measurements, respectively. This is found to be the best among the related studies. Furthermore, a single-detector multiple-source arrangement resulted in a Pearson r value of 0.97 for the wrist. The Bland-Altman bias values were found to be -0.003 ± 0.36, 0.01 ± 0.25, and 0.01 ± 0.21, for the two fingertip and wrist models, respectively, which conform to the standards of the current state-of-the-art invasive point-of-care devices. The implementation of these algorithms will be a suitable alternative to the invasive state-of-the-art methods.

Comparison of NGSP Certified Methods and their Cost Analysis for Estimation of HbA1c- A Cross-sectional Study

Introduction: Diabetes Mellitus (DM) is a major non communicable disease that adversely impacts the health of the global community, contributing significantly to mortality. Estimation of glycated haemoglobin (HbA1c) is an integral component of diagnosis, treatment and follow-up of cases of DM as the various protocols have included it for therapy. In order to regularise the estimation of HbA1c, it is mandated by American Diabetes Association (ADA) to perform the test on NGSP certified methods only. Aim: To compare the results of HbA1c analysis by SIEMENS DIMENSION EXL 200 and BIORAD D-10 (NGSP certified methods). Materials and Methods: This was a cross-sectional observational study done in Department of Biochemistry, Armed Forces Medical College, Pune, Maharashtra, a tertiary care center. One hundred and twenty blood samples in EDTA tubes for haemoglobin variant analysis, received from patients with unexplained anaemia or screening for antenatal care were included in the study. The tests for HbA1c were performed by HPLC based BIORAD D10 and enzymatic based method, SIEMENS DIMENSION EXL 200 analyser. Cost analysis of both the methods was also performed. Students paired t-test was done to look for any significant statistical difference. Kappa coefficient was also calculated to analyse for agreement between values. Results: HbA1c estimation by SIEMENS DIMENSION EXL200 and BIORAD D-10 (both NGSP certified) showed marginally different results, but it was not significant enough to make a clinical difference (5.308% on BIORAD D10 and 5.211% on SIEMENS DIMENSION EXL 200). On performing the cost analysis, there was a significant difference observed with a figure of Rs 476.05/- per test on the SIEMENS DIMENSION EXL200, while it was significantly cheaper at Rs 266/- per test on the BIORAD D10. Conclusion: Estimation of HbA1c on SIEMENS DIMENSION EXL200 and BIORAD D10 was not clinically significant. As per cost analysis, BIORAD D10 is a cheaper alternative and suitable for tertiary care or large volume centres.

High Sensitivity Cardiac Troponin-T STAT in Type 2 Diabetes Mellitus Patients and Healthy Individuals: A Comparative Study

Introduction: Diabetes Mellitus (DM) is a metabolic disorder that shares the phenotype of hyperglycaemia, with several factors contributing to the disease, including decreased insulin secretion and glucose utilisation, as well as increased glucose production. There is a strong association between DM and Cardiovascular Disease (CVD). High-sensitivity cardiac troponin T (hs-cTnT), which is a marker of subclinical myocardial damage, is used in the risk stratification of asymptomatic individuals. Aim: To estimate and compare hs-cTnT Short Turn Around Time (STAT) levels in diabetic patients without Acute Myocardial Infarction (AMI) with age and sex matched controls and also to investigate the correlation between hs-cTnT STAT and Glycated Haemoglobin (HbA1c) levels. Materials and Methods: A comparative cross-sectional study was conducted in the Department of Biochemistry and Outpatient Clinic, Department of Medicine, Government Medical College, Kozhikode, Kerala, India, from April 2019 to April 2020. The study subjects were divided into two groups: Group 1 consisted of 58 patients with Type 2 Diabetes Mellitus (T2DM) without AMI, and Group 2 comprised 58 healthy individuals who were age and sex matched. No specific sampling technique was employed. After obtaining consent, T2DM patients who attended the outpatient clinic were evaluated with fasting blood glucose, HbA1c, Electrocardiogram (ECG), and hs-cTnT STAT estimation. Controls were selected and evaluated for the same from apparently healthy bystanders of other patients, medical and paramedical staff, and others willing to participate. Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 22.0 software. Results: The mean value of Fasting Blood Sugar (FBS) and HbA1c was higher in T2DM patients compared to healthy individuals. hs-cTnT showed a positive moderate correlation with HbA1c (rho=0.53), which was statistically significant (p-value&lt;0.001). Simple linear regression analysis showed that in the case group, for a 1% increase in HbA1c levels, there was a 2.38 unit increase in hs-cTnT levels, which was statistically significant (p-value&lt;0.001). Conclusion: hs-cTnT levels are significantly elevated in T2DM patients without overt CVD compared to age and sex matched healthy individuals. T2DM is a risk factor for increased levels of biomarkers for atherosclerotic CVD, and proper glycaemic control reduces the levels of hs-cTnT in T2DM patients.

DISTURBANCES IN SERUM CALCIUM AND PHOSPHATE LEVELS IN PRE-DIABETES AND TYPE 2 DIABETES MELLITUS

Objective: To evaluate serum calcium and phosphate levels in Pre-diabetic, Diabetic &amp; non-diabetic subjects. Material and Methods: This comparative cross-sectional study was conducted at the Department of Chemical Pathology and Endocrinology, Armed Forces Institute of Pathology, from July to December 2021. The study used a non-probability consecutive sample to include 300 people. Those people have been divided into three groups; diabetics, pre-diabetics and non-diabetics with a hundred people in every group. Blood specimens had been taken for the estimation of calcium, phosphate, HbA1c, plasma glucose and insulin in fasting in their respective tubes. SPSS version 24 was used to inspect the data. All descriptive variables had their means and standard deviations calculated. To examine descriptive characteristics within and between all groups, one way ANOVA and post hoc LSD were performed, and p-values 0. 05 were considered significant. Results: Calcium and Phosphorus levels were lower in Diabetic group (Ca= 1.97±0.16mmol/l, PO4 = 0.76±0.07 mmol/l) as compared to pre-diabetic group (Ca= 2.15±0.18 mmol/l, PO4 = 0.93±0.06 mmol/l) and higher in non-diabetic group (Ca= 2.33±0.10mmol/l, PO4 = 1.19±0.20 mmol/l) than both other groups. A one-way ANOVA and Post Hoc LSD revealed that the difference between and within groups was statistically significant with a p value of 0.01. Conclusion: Our research has shown that as glycemic control slowly deteriorates, blood calcium and phosphate levels fall. Keywords: Calcium, Phosphorus, Pre-diabetes, Type 2 diabetes mellitus.

Variation of HbA1c with Hemoglobin level: A comparative study between High Performance Liquid Chromatography and Immunochromatography Analyzer

Introduction: The measurement of glycated hemoglobin (HbA1c) is an established procedure in evaluating long-term glycemic control in diabetic patients. There are many factors like temperature, pH, lifespan of protein, substrate concentrations and hemoglobin levels that influence HbA1c estimation by any methods. The aim of the study is to estimate HbA1c by High Performance Liquid Chromatography (HPLC) and immunochromatography analyzer and find the influence of hemoglobin in HbA1c by both the methods. Methods: This was a descriptive, cross-sectional study carried out in the department of Biochemistry of Shree Birendra Hospital, Chhauni, Kathmandu over a period of two months from May 2021 to June 2021. We selected patients with type 2 diabetes mellitus. HbA1c was measured in EDTA blood samples by Bio-Rad D10 (HPLC method) and Nycocard (Immunochromatography method) whereas hemoglobin was estimated using Horiba Penta XLR fully automated hematology analyzer. Results: In our study of 100 known cases with type 2 diabetes mellitus, the mean hemoglobin level was 14 ± 2.09 g/dL. The mean HbA1c value obtained by Nycocard and HPLC analyzer were 7 ± 1.95 % and 7.39 ± 2.21% respectively. We found that there was a strong correlation of HbA1c values with hemoglobin levels in HPLC method p = 0.001, r = 0.6. However, we found no such correlation by Nycocard method p = 0.6, r = 0.08. Conclusion: There was a positive correlation of hemoglobin with HbA1c values obtained by HPLC method however no such variation was seen with immunochromatography method. This suggests that estimating HbA1c by HPLC methods may show decreased HbA1c with decreased hemoglobin levels and increased HbA1c with increased hemoglobin levels.